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Gleason Score, Prostate-Specific Antigen Level, and Cancer Stage in Predicting Outcome in Patients Who Have Undergone Radiation Therapy for Localized Prostate Cancer
This study is currently recruiting participants.
Study NCT00769223   Information provided by National Cancer Institute (NCI)
First Received: October 8, 2008   Last Updated: May 9, 2009   History of Changes

October 8, 2008
May 9, 2009
February 1993
February 2013   (final data collection date for primary outcome measure)
Value of the pre-operative Gleason score, prostate-specific antigen level, and clinical stage in predicting the risk of failure and death [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00769223 on ClinicalTrials.gov Archive Site
 
 
 
Gleason Score, Prostate-Specific Antigen Level, and Cancer Stage in Predicting Outcome in Patients Who Have Undergone Radiation Therapy for Localized Prostate Cancer
Pre-Operative Gleason Score and PSA and Clinical Stage in Predicting the Risk of Failure in Patients Undergoing Radiation Therapy for Localized Prostate Cancer

RATIONALE: Gathering information about the Gleason score, prostate-specific antigen (PSA) level, and cancer stage from patients who have undergone radiation therapy for prostate cancer may help doctors predict how patients respond to treatment and help plan the best treatment.

PURPOSE: This clinical trial is studying the Gleason score, PSA level, and cancer stage in predicting outcome in patients who have undergone radiation therapy for localized prostate cancer.

OBJECTIVES:

  • Evaluate the value of the pre-operative Gleason score, prostate-specific antigen level, and clinical stage in predicting the risk of failure and death in patients who have undergone radiotherapy for localized prostate cancer.

OUTLINE: This is a multicenter study.

Patient medical records are reviewed to collect data about pre-treatment prostate biopsy, assigned Gleason score, prostate-specific antigen level, and radionucleotide bone scan.

Patients complete a Bowel Toxicity questionnaire to assess quality of life related to acute and long-term bowel toxicity after radiotherapy.

 
Observational
 
  • Prostate Cancer
  • Radiation Toxicity
  • Other: medical chart review
  • Other: questionnaire administration
  • Procedure: quality-of-life assessment
  • Radiation: brachytherapy
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
3500
 
February 2013   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of localized adenocarcinoma of the prostate
  • Has undergone radiotherapy (external beam radiotherapy and/or brachytherapy) with or without hormonal therapy for adenocarcinoma of the prostate in the UCSF Radiation Oncology Department at San Francisco General Hospital or Veterans Administration Medical Center of San Francisco between 1987 and 2006

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Male
 
No
 
United States
 
NCT00769223
Mack Roach, III, UCSF Helen Diller Family Comprehensive Cancer Center
CDR0000597000, UCSF-H7056-08989
UCSF Helen Diller Family Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Mack Roach, MD UCSF Helen Diller Family Comprehensive Cancer Center
National Cancer Institute (NCI)
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP